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Medical Device Recalls
Class 2 Recall
Puritan Bennett KnightStar Ventilator
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Date Recall Initiated |
August 31, 2006
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Date Posted |
January 09, 2007
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Recall Number |
Z-0444-2007
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Product |
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
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Code Information |
All units are subject to this notice (all serial numbers).
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Recalling Firm/ Manufacturer |
Puritan Bennett Corporation
5931 Priestly Dr Ste 100
Carlsbad
, California
92008-8813
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For Addition Information Contact |
Michael P. Spears
925-463-4082
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Reason For Recall |
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
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Action |
Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
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Quantity in Commerce |
7,754 (in US)
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Distribution |
Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
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